国产抗结核固定剂量复合剂治疗初治涂阳肺结核患者的近期疗效观察

目的探讨国产抗结核固定剂量复合剂在结核病防治规划中应用的可行性。方法采用随机分组方法将422例初治涂阳肺结核患者分为试验组(219例)和对照组(203例)。试验组在2个月强化期每日服用异福酰胺片[含利福平(R)120mg,异烟肼(H)80mg和吡嗪酰胺(Z)250mg],4个月巩固期每日服用异福片(含R300mg,H150mg);对照组采用标准6个月短程化疗方案2HRZE/4H3R3(Z为乙胺丁醇)。结果试验组和对照组年龄、性别构成,以及治疗前病情(痰菌含量、肺部病变累及范围和空洞形成)等组间差异均无显著性。采用固定剂量复合剂短程化疗2个月、3个月和6个月痰菌转阴率分别为916%、972%和977%,对照组分别为873%、975%和980%,两组疗效比较差异无显著性(χ21=205,χ22=003,χ23=004,P>005)。不良反应中皮疹发生率试验组低于对照组(Fisher精确法P=002433)。结论国产抗结核固定剂量复合剂可作为目前国家结核病防治规划使用的抗结核药的补充,供基层选用,但仍需进一步验证。

Randomized control study on domestic fixed-dose combinations in the initial treatment of smears positive tuberculosis

OBJECTIVE: To explore the feasibility of domestic fixed-dose combinations as antituberculosis therapy applied in the National Tuberculosis Program. METHODS: A randomized control trial was conducted and 422 smear-positive pulmonary tuberculosis patients were randomly distributed into 2 groups. The trial group was treated daily with rifampicin, isoniazid and pyrazinamide tables (including 120 mg rifampicin, 80 mg isoniazid and 250 mg pyrazinamide) in the first 2 months and rifampicin and isoniazid tables (including 300 mg rifampicin, 150 mg isoniazid) in the subsequent 4 months. The control group was treated by full 6-month standard regimens (2HRZE/4H3R3). RESULTS: The demographic data and the disease status were similar between the 2 groups before treatment. The rate of conversion from positive to negative cases in the trial group after therapy was 91.6% at 2 months, 97.2% at 3 months, and 97.7% at 6 months, while that of the control group was 87.3%, 97.5%, and 98.0% respectively. The difference in the conversion rates between the two groups was not statistically significant (chi2 = 2. 05, chi2 = 0.03, chi2 = 0.04, P > 0.05). The incidence of skin rash as an adverse effect was less common in the trial group as compared to the control group (Fisher's exact P = 0.024 33) . CONCLUSIONS: Domestic fixed-dose combinations as supplementary anti-tuberculous therapy could be used in the National Tuberculosis Program, but further study is needed for widespread application.